DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Nab-paclitaxel Combined With Gemcitabine as Adjuvant Therapy for Pancreatic Cancer After Curative Resection

Information source: Fudan University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stage IA Pancreatic Adenocarcinoma; Stage IB Pancreatic Adenocarcinoma; Stage IIA Pancreatic Adenocarcinoma; Stage IIB Pancreatic Adenocarcinoma

Intervention: nab-paclitaxel (Drug); gemcitabine (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Xian-Jun Yu

Official(s) and/or principal investigator(s):
Xian-Jun Yu, M.D., Ph.D., Principal Investigator, Affiliation: Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Overall contact:
Xian-Jun Yu, M.D., Ph.D., Phone: +86-21-64175590, Email: yuxianjun88@hotmail.com

Summary

Pancreatic cancer has an extremely poor prognosis with a 5-year survival rate of less than 5%. About 25% of patients have the opportunity for radically surgical resection when diagnosis. However, the recurrence rate is up to 85% within 2 years. Data from clinical trials indicated that gemcitabine-based adjuvant chemotherapy reduced recurrence and enhanced overall survival for patients who have undergone surgery to remove their tumor. Nab-paclitaxel could enhance the intratumoral concentration of gemcitabine; recent studies showed that nab-paclitaxel plus gemcitabine significantly improved progression-free survival and overall survival of metastatic pancreatic cancer patients. The present study is intended to investigate the activity and safety of the combination of gemcitabine and nab-paclitaxel as adjuvant chemotherapy in treating patients with pancreatic cancer after curative resection.

Clinical Details

Official title: A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine in Treating Patients With Pancreatic Cancer After Curative Resection

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Recurrence-free survival at one year after curative resection

Secondary outcome:

Overall survival after curative resection

Quality of life score after curative resection

Number of grade 3 and 4 toxicities according to NCI CTCAE version 4.0

CA199 level after curative resection

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Signed informed content obtained prior to treatment

- Age ≥ 18 years and ≤ 75 years

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Patients must have histologically confirmed pancreatic adenocarcinoma (or any mixed

pathology if adenocarcinoma is predominant) after curative resection (R0). The pathological staging does not exceed the stage IIB.

- No tumor lesions are seen by abdominal and thoracic CT scan 4~8 weeks after surgery,

and no serious adverse events are occurred during this period

- The expected survival after surgery ≥ 6 months

- White blood cell (WBC) ≥ 3 × 109/L; Absolute neutrophil count (ANC) ≥ 1. 5 × 109/L;

Platelets (PLT) ≥ 100 × 109/L; Hemoglobin (Hgb) ≥ 9 g/dL

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/

alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) ≤ 2. 5 × institutional upper limit of normal (ULN); Total bilirubin (TBIL) ≤ ULN; Creatinine (CRE) ≤ 1. 5 × ULN

- Prothrombin time (PT) and international normalized ratio (INR) ≤ 1. 5 × ULN

Exclusion Criteria:

- Active second primary malignancy or history of second primary malignancy within the

last 3 years

- Patients who have received any form of anti-tumor therapy before surgery, including

chemotherapy, radiotherapy, interventional chemoembolization, radiofrequency ablation, and molecular targeted therapy

- Use of any other investigational agents

- Patients with uncontrolled intercurrent illness including, but not limited to ongoing

or active infection, internal hemorrhage, pancreatic leakage, bile leakage, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

- History of allergic reactions attributed to compounds of similar chemical or

biological composition to nab-paclitaxel or gemcitabine

- Metabolic acidosis, acute or chronic, including ketoacidosis

- Pregnant or nursing women

- Human immunodeficiency virus (HIV)-positive patients

- Patients who are unwilling or unable to comply with study procedures

Locations and Contacts

Xian-Jun Yu, M.D., Ph.D., Phone: +86-21-64175590, Email: yuxianjun88@hotmail.com

Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China, Shanghai 200032, China; Recruiting
Xian-Jun Yu, M.D., Ph.D., Phone: +86-21-64175590, Email: yuxianjun88@hotmail.com
Liang Liu, M.D., Ph.D., Phone: +86-21-64175590, Email: liuliang.zlhospital@gmail.com
Xian-Jun Yu, M.D., Ph.D., Principal Investigator
Additional Information

Starting date: January 2014
Last updated: March 5, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017